FDA Clamps Down on Gene-Testing Company

The gene-testing firm 23andMe has not received approval for its product and must stop marketing its test for the time being, the FDA announced.

The gene-testing firm 23andMe has not received approval for its product and must stop marketing its test for the time being, the FDA announced.

The Mountain View, Calif., company's Saliva Collection Kit and Personal Genome Service (PGS) is being marketed "without marketing clearance or approval in violation of the Federal Food, Drug and Cosmetic Act (the FD&C Act)," the agency said in a letter to the company posted on the FDA website Monday. "Therefore, 23andMe must immediately discontinue marketing the PGS until such time as it receives FDA marketing authorization for the device."

The agency noted that 23andMe is marketing its test as being able to provide information about 254 diseases, "including categories such as 'carrier status,' 'health risks,' and 'drug response,' and specifically as a 'first step in prevention' that enables users to 'take steps toward mitigating serious diseases' such as diabetes, coronary heart disease, and breast cancer."

"Most of the intended uses for PGS listed on your website, a list that has grown over time, are medical device uses under section 201(h) of the FD&C Act," the agency continued. "Most of these uses have not been classified and thus require premarket approval or de novo classification, as FDA has explained to you on numerous occasions."

The FDA said it was especially concerned about some of the assessments that the company makes from the gene test data, including presence of BRCA genes which confer a higher risk of breast and ovarian cancer, as well as indications of warfarin sensitivity, clopidogrel response, and 5-fluorouracil toxicity, "because of the potential health consequences that could result from false positive or false negative assessments for high-risk indications such as these.

"For instance, if the BRCA-related risk assessment for breast or ovarian cancer reports a false positive, it could lead a patient to undergo prophylactic surgery, chemoprevention, intensive screening, or other morbidity-inducing actions, while a false negative could result in a failure to recognize an actual risk that may exist."

The agency noted that the company has submitted several 510(k) approval applications for various indications, but never provided additional information that the FDA asked for, so its applications were considered to be withdrawn.

In response, 23andMe issued a one-paragraph statement. "We have received the warning letter from the Food and Drug Administration," the company wrote on its website. "We recognize that we have not met the FDA's expectations regarding timeline and communication regarding our submission. Our relationship with the FDA is extremely important to us and we are committed to fully engaging with them to address their concerns."

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